Real Lean Blogs

Managing Non-Routine Work

Published by Adrian Fegan in Lean Laboratory, Lean QA on April 11, 2018

Every Department (QC, QA, R&D, RA, Manufacturing, etc.) has its share of non-routine work that must be completed.  This can include new instrument qualifications, method validations/transfers, SOP reviews, batch record updates, etc. It is easy for these tasks to get lost in the mix of all the other work. This is of course until there is a hard deadline or annual reviews are approaching! Then resources have to be dedicated to these non-routine projects to ensure that they are completed on time. While this is happening routine work is building up and once the project is cleared we have to set about dealing with the backlog.

Time studies, work measurement and standards - how not to alienate your team

Published by Andrew Harte in Lean Laboratory, Lean R&D on April 11, 2018

A critical component of improving any existing process is first measuring it! “If you can’t measure it, you can’t improve it.” (Bohmer, 2008) There are multiple tools for determining a process’ baseline, such as process mapping and spaghetti diagrams. Possibly, some of the more controversial tools are those used for work measurement and standards. There are four recognized methods for gathering information on the time it takes to perform a task (or set of tasks).

Designing Visual Management for a Lean Laboratory

Published by Noelani Roy in Lean Laboratory on April 11, 2018

Visual management is an integral part of a Lean Laboratory. It unites personnel around a common goal, ensures that critical information is disseminated, and keeps the lab running smoothly. When a visual management board is well designed, anyone should be able to walk in and have a clear understanding of the labs operational status and current performance. 

Use Real Lean as your first step to release capacity

Published by Ger Conolin in Lean QA, Lean R&D on September 2, 2015

Faced with a need to increase laboratory testing capacity, Real Lean releases hidden capacity quickly and cost effectively.

Increased demand for lab capacity is a positive indicator of a growing business.  Deciding upon the best option to increase capacity, however, never seems to be easy!  In particular, when existing space, equipment and staffing capacity is thought to be maxed out, the next option tends to involve a space expansion (see the top row of graphic below) – a complex project with significant capital expenditure, which drags stakeholders from Engineering and Facilities, Finance and HR into the mix.

Real Lean – What's in a name?

Published by Ger Conolin in Lean Laboratory, Lean QA, Lean R&D on August 28, 2015

Real Lean is the term used by BSM to describe a specific methodology, one which enacts the actual core principles of lean and delivers real value stream optimisation, both financially and operationally, for its clients.    

Real Lean: A Specific Approach to Generics

Published by Melanie Watson in Lean Laboratory on August 20, 2014

Ever since its first introduction by the Japanese automotive industry in the 1980s, lean manufacturing has been successfully adopted by many companies. For more than 10 years BSM have been global leaders in the provision of “Real Lean”. Now, BSM are implementing “Real Lean” in the generics Life Science industry. This effort is not without its difficulties, providing many unique challenges and customization of the lean process.

Importance of including Lab Planners when designing Lean Lab solutions

Published by Cathal Boyce in Lean Laboratory, Lean R&D on May 30, 2014

When designing lab solutions, Analysts, Lab Managers, Supervisors and Approvers are all important stakeholders.  The solution will be designed so that these stakeholders can carry out their tasks as efficiently and obstruction-free as possible.  However, it shouldn’t be forgotten that the lab Planner is also a critical stakeholder, and planning of the workload, both for the lab as a whole and for individual analysts, is the first step to ensuring a levelled workload and flow through the lab.

Applying Lean to the Lab through Visual Management

Published by Preston Chandler in Lean Laboratory, Lean R&D on November 8, 2013

The effort to make the work and processes visible, in a work environment, is called visual management. In general, there are a couple of key items for any successful application of visual management. 

Structured Problem Solving – the Missing Link in Labs

Published by Patrick Conneran in Lean Laboratory, Lean R&D on November 6, 2013

Structured Problem Solving has been one of the foundations of Lean transformation, and of almost any high performing company over the past 50 years. However, many labs reject Structured Problem Solving techniques outright, or use them as a ‘box – ticking’ exercise to satisfy management that they are adhering to the latest directive. Why is it, when successful organisations pride themselves on a culture of continuous improvement and problem-solving, that in Labs, it is often the missing link to true transformative improvements…?

The ‘Checklist Manifesto’ - Saving Lives with Standard Work…?

Published by Patrick Conneran in Lean QA on September 11, 2013

A recent bestseller expounds the benefits of a simple tool that is being used to save lives in hospitals around the world. How can we apply the same tool to improve quality outcomes in other processes?

Paperwork Review in QC Labs – are Dedicated Resources a good idea?

Published by Melanie Watson in Lean Laboratory, Lean QA on September 9, 2013

Pharmaceutical testing laboratories face many challenges including high volatility in incoming workloads, non-optimized analyst roles and undefined testing sequences. These issues are often ‘managed’ by dedicating resources to specific tasks and creating subject-matter experts in an attempt to improve performance and reduce errors. More recently there has been a move towards dedicated reviewers, where analysts are “promoted” off the bench into full-time review roles.

Lean QA - Audit Management

Published by Patrick Conneran in Lean QA on August 21, 2013

Most pharmaceutical companies have a cGMP auditing program administered at the site and corporate levels of the organization. Given the success seen through the implementation of Lean in QC and Manufacturing, many organizations wish to extend these initiatives to their audit function in order to improve productivity and service level, and lower costs. However, faced with a constantly evolving regulatory environment and increasingly varied processes and facility types (manufacturing, warehousing, contractors, suppliers etc.), can Internal Audit functions improve their operational effectiveness while maintaining the same level of regulatory oversight?

Lean QA - Audit Management

Published by Patrick Conneran in Lean QA on August 21, 2013

Most pharmaceutical companies have a cGMP auditing program administered at the site and corporate levels of the organization. Given the success seen through the implementation of Lean in QC and Manufacturing, many organizations wish to extend these initiatives to their audit function in order to improve productivity and service level, and lower costs. However, faced with a constantly evolving regulatory environment and increasingly varied processes and facility types (manufacturing, warehousing, contractors, suppliers etc.), can Internal Audit functions improve their operational effectiveness while maintaining the same level of regulatory oversight?

Lean in Regulatory Operations

Published by Alan Maloney in Lean RA on July 25, 2013

BSM have been pioneering applied research into the utilization of Real Lean methodologies to solve problems and generate efficiencies in Regulatory Affairs Operations (Reg Ops) in large life science companies. Operations from a Regulatory perspective encompasses the standard activities that accompany the filing of Regulatory submissions such as Labelling, Publishing, Production, Archiving etc. “Real Lean” is the term used to describe BSM’s approach to implementing Lean in a wide variety of industrial settings. We use this term to distinguish our approach from generic Lean implementations which primarily focus on elimination of the seven wastes. “Real Lean” has at its core a commitment to incorporate the key principles of Levelling, Flow and Standard Work as a basic operating system. 

Making Sense of the Chaos in Laboratories

Published by Preston Chandler in Lean Laboratory, Lean R&D on May 23, 2013

To an outsider (and often even the insiders) laboratories can seem like a workplace hovering on the brink of chaos. The lab is constantly bombarded with hot requests for this lot or a special test for that project.  Investigations, vacations, changes in product, adjustments in mix, FDA inspections, equipment issues and narrowly specialized analysts can often add to this sense of chaos.  Usually it is difficult to see how work flows in the lab, if in fact it does flow.  It can also be next to impossible to identify what is “normal” behavior.  One of the critical steps in creating a Lean Lab is separating the routine (or in some cases, the most routine) from the non-routine or non-predictable.

Slow down… so that you can speed up

Published by Preston Chandler in Lean Laboratory, Lean QA on April 2, 2012

Slow down....so that you can speed up. Sounds like something Yoda would say. Component sub-optimization for increased system performance. 

5S in labs; a waste of time, right?

Published by Karen Wrafter in Lean Laboratory, Lean R&D on August 31, 2011

Deployment of 5S in a laboratory setting is a time consuming effort and one which in itself delivers little in terms of productivity gains. So why bother…?

Lean Thinking for Laboratories

Published by Tom Reynolds in Lean Laboratory, Lean R&D on May 5, 2011

While it might sound like some sort of fad diet, “lean” in the context of business improvement refers to a specific methodology that originated in the Japanese motor industry toward the end of the 1980s. Over the decades, this lean philosophy has been successfully adopted by many companies across a broad spectrum of industries and, more recently, lean thinking has filtered into laboratories. The focus of a lean laboratory is to test samples in the most efficient way possible in terms of cost, or speed, or both. Although most of the key principles of lean apply in labs, the specific challenges facing laboratories require significant adaptation of standard lean tools. 

Synchronising Planning, Manufacturing & QC

Published by Karen Wrafter in Lean Laboratory, Lean Manufacturing on June 10, 2010

Day to day operations of individual departments in life science companies rely on many decisions made outside of each department’s own remit. When embarking on a Lean strategy, the pillars of operational excellence (Levelling and Flow) can be supported by increasing awareness of how each department functions and explaining constraints.

Why are Lab SOPs and Work Instruction so Bad?

Published by Karen Wrafter in Lean Laboratory on May 11, 2010

Typically, laboratory Standard Operating Procedures and Work Instructions are wordy, patch-worked documents and a hindrance to testing analysts and reviewers alike. Over their life cycle, procedures usually become increasingly difficult to decipher due to multiple disjointed revisions. As a result, training and routine testing often relies on the retained knowledge of key experienced personnel, with an accepted culture of ‘Chinese whispers’. This dependence on undocumented hints and reminders can be tackled by applying Lean thinking to the design and layout of Laboratory SOP’s.

Small dedicated work groups: (A misapplication of the value stream concept)

Published by Tadgh Prendeville in Lean Laboratory on May 11, 2010

Recently in laboratories, there has been a notable shift towards dedicating resources to specific work streams and sub-streams, in the attempt to improve service levels. This is due in large part to a misapplication of the key Lean principle of developing ‘Value Streams’.